653A comparison of clinical outcomes of subcutaneous and transvenous implantable defibrillator therapy in the SIMPLE and EFFORTLESS studies
Bibliographic record
Abstract
Funding Acknowledgements: Boston Scientific Corporation Introduction: Comparison of clinical outcomes of subcutaneous and transvenous implantable cardioverter-defibrillator (S-ICD and TV-ICD) therapy is important to determine the optimal treatment strategy in ICD candidates without need for bradycardia or anti-tachycardia pacing. Purpose: To compare device related-complications, appropriate and inappropriate shocks in patients implanted with S-ICDs and TV-ICDs in a multicenter cohort with propensity score correction. Methods: All patients implanted with de novo ICDs without need for pacing at baseline were selected from two contemporary multicenter studies: SIMPLE (n=1091 single chamber and n=553 dual chamber TV-ICDs) and EFFORTLESS (n=843 S-ICDs). For all patients with available baseline data, a propensity score for device type (TV-ICD versus S-ICD) was calculated based on eleven baseline variables including diagnosis, age, indication and atrial fibrillation in order to account for differences in baseline characteristics of the two cohorts. Complications were defined as those that were device-related and required invasive intervention. Inappropriate shocks were defined as shocks not delivered for ventricular tachycardia or ventricular fibrillation. All endpoints were adjudicated by an internal adjudication committee of the sponsor of both studies. Hazard ratios and 95% confidence intervals (95%CI) were calculated via Cox modeling, stratified by propensity score decile. Results: At baseline (n=2487, 100%), S-ICD patients were significantly younger (48±17 versus 62±12, P<0.001) and less often had ischemic cardiomyopathy (32.3% versus 67.6%, P<0.001). For 2431 patients (97.7%) a propensity score could be calculated and were retained in the analysis. The median follow-up was 3.0 years in the S-ICD arm versus 3.3 years in the TV-ICD arm. The propensity score adjusted hazard ratio for device-related complications was 1.16 (95%CI 0.84, 1.61). Excluding the operators’ learning curve for S-ICD implants (first 12 per implanter) did not change results significantly. The propensity score adjusted hazard ratios for appropriate and inappropriate shocks were 0.69 (95%CI 0.46, 0.84) and was 1.32 (95%CI 0.95, 1.83), respectively. A secondary sensitivity analysis of 1-to-1 matching yielded 404 patients pairs and demonstrated similar results. Conclusion: In this propensity score corrected analysis of two large multicenter cohorts, the first generation S-ICD had similar clinical outcomes over a three year follow-up duration when compared to a contemporary TV-ICD cohort with predominately single chamber devices.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".